# GMP Medicare Sdn Bhd(F25) · 89-08 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

For GMP Medicare Sdn Bhd(F25) · 89-08 · MALAYSIA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is MALAYSIA; product is Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black; product code is 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs; date published is 08/23/2022; address is Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor MALAYSIA, verified against its source on 2026-09-16.

- **Firm:** GMP Medicare Sdn Bhd(F25) _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 08/23/2022 _(verified: appears in the quote below)_
- **Product code:** 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs _(verified: each item appears in the quote below)_
- **Product:** Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black _(verified: each item appears in the quote below)_

## What the source says

> GMP Medicare Sdn Bhd(F25) Date Published : 08/23/2022 Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor MALAYSIA 80 L - - YY Glove, Patient Examination, Latex Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 80 L - - YY Glove, Patient Examination, Latex Date Published: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 80 L - - YY Glove, Patient Examination, Latex Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 80 L - - ZA Glove, Patient Examination, Poly Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 80 L - - ZA Glove, Patient Examination, Poly Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 80 L - - ZA Glove, Patient Examination, Poly Date Published: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).